Lack of regulatory plan could slow scientific advancement and deter public confidence

Washington, DC – Researchers are using biotechnology to develop genetically modified (GM) insects for a wide variety of purposes, including fighting insect-borne diseases like malaria and controlling destructive insect agricultural pests, but the federal government lacks a clear regulatory framework for reviewing environmental safety and other issues associated with GM insects, according to Bugs in the System? Issues in the Science and Regulation of Genetically Modified Insects, a new report released today by the Pew Initiative on Food and Biotechnology.

The report provides an overview of current research efforts to apply genetic engineering technology to insects, and looks at the benefits, risks and scientific uncertainties associated with transgenic insects. After examining the strengths and weaknesses of the legal authorities EPA, FDA and USDA could use to conduct a regulatory review, the report finds the major concern regarding regulation is the absence of a clear articulation of how transgenic insects will be regulated. While a number of laws could potentially apply to GM insects, federal regulators have not indicated if they would regulate GM insects, how a regulatory review would be conducted, which agencies would be involved, or how those agencies would coordinate.

"Although it may be several years before scientists are ready to conduct a wide scale release of transgenic insects, the research threatens to outpace regulatory preparedness," said Michael Rodemeyer, executive director of the Pew Initiative on Food and Biotechnology. "The benefits of GM insects could be significant, but the federal government needs to move quickly to clarify how it will provide an adequate review of these insects and the many questions they raise regarding the environment, public health, agriculture and food safety."

Scientists are currently working to genetically modify insects to address important economic and human health concerns. If successful, GM insects could dramatically improve public health and enhance agricultural production. Examples include:

Mosquitoes incapable of transmitting malaria, which is contracted by 300 - 500 million people annually and kills between one and three million people worldwide each year.

Honeybees genetically engineered so they are resistant to diseases and parasites, which have devastated the honeybee population in the last decade.

Silkworms made to produce pharmaceutical and industrial proteins, like those used to create a particularly strong spider silk that could be used to make bulletproof vests, parachutes, and artificial ligaments.

Kissing bugs unable to transmit Chagas' disease, which currently infects 16 - 18 million people annually and kills nearly 50,000 people worldwide each year.

However, there is uncertainty about the lasting effects these insects could have on ecosystems, public health and food safety once released. For instance, the success of some GM insects is contingent on the ability of fertile GM insects to replace wild insect populations and become established in the environment. Release of fertile GM insects increases the potential that transgenic traits could spread throughout the insect population, potentially making pre-existing pest problems worse or creating altogether new challenges. It is also possible that GM insects released to control the spread of disease could actually have the unintended consequence of enabling an insect to more effectively spread disease or even carry a human disease it was never before able to transmit. Lastly, there is the possibility that modifying the genetic composition of honeybees could alter the composition of the honey they produce, potentially creating a food safety concern. All of these uncertainties will need to be addressed by regulators prior to the introduction and release of GM insects.

The federal government currently has no comprehensive policy on how transgenic insects will be reviewed. Under existing laws, at least three different agencies – the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Department of Agriculture (USDA) – could have some authority over certain kinds of GM insects. But only USDA has issued regulations that cover any type of GM insect (USDA requires regulatory approval of any field trials of GM insects that are potential plant pests.) No single agency appears to have authority to consider all of the issues raised by the many different types of GM insects being developed, and agencies have not indicated how, or if, they intend to coordinate their respective authorities to provide a comprehensive framework for regulation. Without clarification about how transgenic insects will be regulated, it is difficult to determine if the unique issues raised by transgenic insects will be addressed in a manner that inspires public confidence and provides the scientific community with adequate guidance.

The absence of regulatory clarity regarding domestic GM insect activity has broader implications. The mobility and range of insects pose international regulatory challenges never faced with GM crops, and much of the public health research underway seeks to address insect-borne diseases most prevalent outside the U.S, meaning international regulatory bodies will likely be engaged before any insects are released. Because U.S. regulatory policies will be an important building block in the development of international policies regarding GM insects, domestic stagnation impedes development on an international level.

"Clarity from U.S. regulators would benefit both the scientific community and the public at large," concluded Rodemeyer. "Without a clear and transparent roadmap for regulation, it is difficult for scientists to know how to proceed with research efforts and the public has little reason to trust that the risks and benefits are being appropriately weighed and measured."

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By John M. Grohol, Psy.D. on
21 Feb 2009
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